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Publications

Abstracts of NWRSCIS articles published during the 2011-2016 grant cycle

 

2016

 Arch Phys Med Rehabil. 2016 May 4.  
To What Extent Do Neighborhood Differences Mediate Racial Disparities in Participation After Spinal Cord Injury?
Botticello AL, Boninger M, Charlifue S, Chen Y, Fyffe D, Heinemann A, Hoffman JM, Jette A, Kalpakjian C, Rohrbach T.
OBJECTIVE: To examine the role of residential neighborhood characteristics in accounting for race disparities in participation among a large sample of community-living adults with chronic spinal cord injury (SCI). DESIGN: Secondary analysis of cross-sectional survey data from the national Spinal Cord Injury Model Systems (SCIMS) database linked with national survey and spatial data. SETTING: SCIMS database participants enrolled at 10 collaborating centers active in follow-up between 2000 and 2014. PARTICIPANTS: The sample consisted of persons with SCI (N=6892) in 5441 Census tracts from 50 states and the District of Columbia. INTERVENTION: Not applicable. MAIN OUTCOME MEASURE: The Craig Handicap Assessment and Reporting Technique was used to measure full participation across 4 domains: physical independence, mobility, occupation, and social integration. RESULTS: Racial minority groups had lower odds of reporting full participation relative to whites across all domains, suggesting that blacks and Hispanics are at risk for poorer community reintegration after SCI. Neighborhood characteristics, notably differences in socioeconomic advantage, reduced race group differences in the odds of full occupational and social integration, suggesting that the race disparities in community reintegration after SCI are partially attributable to variation in the economic characteristics of the places where people live. CONCLUSIONS: This investigation suggests that addressing disadvantage at the neighborhood level may modify gaps in community participation after medical rehabilitation and provides further support for the role of the environment in the experience of disability.

Arch Phys Med Rehabil. 2016 Jun;97(6):929-37.
Evaluating the Psychometric Properties and Responsiveness to Change of 3 Depression Measures in a Sample of Persons With Traumatic Spinal Cord Injury and Major Depressive Disorder.
Williams RT, Heinemann AW, Neumann HD, Fann JR, Forchheimer M, Richardson EJ
OBJECTIVES: To compare the measurement properties and responsiveness to change of the Patient Health Questionnaire-9 (PHQ-9), the Hopkins Symptom Checklist-20 (HSCL-20), and the Hamilton Depression Rating Scale (HAM-D) in people with spinal cord injury (SCI) diagnosed with major depressive disorder (MDD). DESIGN: Secondary analysis of depression symptoms measured at 6 occasions over 12 weeks as part of a randomized controlled trial of venlafaxine XR for MDD in persons with SCI. SETTING: Outpatient and community settings. PARTICIPANTS: Individuals (N=133) consented and completed the drug trial. Eligibility criteria were age at least 18 years, traumatic SCI, and diagnosis of MDD. INTERVENTIONS: Venlafaxine XR. MAIN OUTCOME MEASURES: Patients completed the PHQ-9 and the HSCL-20 depression scales; clinical investigators completed the HAM-D and the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) Dissociative Disorders, which was used as a diagnostic criterion measure. RESULTS: All 3 instruments were improved with rating scale analysis. The HSCL-20 and the HAM-D contained items that misfit the underlying construct and that correlated weakly with the total scores. Removing these items improved the internal consistency, with floor effects increasing slightly. The HAM-D correlated most strongly with Structured Clinical Interview for DSM-IV Dissociative Disorders diagnoses. Improvement in depression was similar on all outcome measures in both treatment and control groups. CONCLUSIONS: The psychometric properties of the revised depression instruments are more than adequate for routine use in adults with SCI and are responsive to clinical improvement. The PHQ-9 is the simplest instrument with measurement properties as good as or better than those of the other instruments and required the fewest modifications.

Arch Phys Med Rehabil. 2016 Apr 12.
Comorbid Traumatic Brain Injury and Spinal Cord Injury: Screening Validity and Effect on Outcomes.
Bombardier CH, Lee DC, Tan DL, Barber JK, Hoffman JM.
OBJECTIVES: To determine the diagnostic accuracy of a self-report measure of traumatic brain injury (TBI) in people with spinal cord injury (SCI), and to assess the potential effect of TBI on acute and post-acute outcomes. DESIGN: Incident TBI as determined by self-report was compared with systematic medical records review by physicians blinded to self-reported TBI. SETTING: Inpatient rehabilitation unit. PARTICIPANTS: From 155 consecutive admissions, participants (N=105; 73% men; mean age, 45.9y; 73% white; 58% with tetraplegia) who met inclusion criteria and were admitted on the day of injury were recruited and assessed. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Step 2 of the Traumatic Brain Injury-4 (TBI-4) interview was used to estimate the presence and severity of TBI.
RESULTS: Estimated incidence of TBI was 33% by chart review and 60% based on Step 2 of the TBI-4. Ninety-one percent of those with TBI based on chart review sustained mild injuries. At the optimal cutoff of "possible TBI," the TBI-4 had a sensitivity of 83% (95% confidence interval, 66%-93%), a specificity of 51% (95% confidence interval, 39%-64%), and a Youden Index of 0.3 (95% confidence interval, 0.2-0.5). Compared with those without TBI, those with chart review-determined TBI had nonsignificant trends toward a longer acute care length of stay and a higher functional status at rehabilitation discharge, but equivalent 1-year outcomes. CONCLUSIONS: Step 2 of the TBI-4 did not meet Youden's criteria (≥0.8) for good diagnostic accuracy in the context of recent SCI. Comorbid TBIs were almost exclusively mild and not associated with poorer outcomes one year after SCI.

Arch Phys Med Rehabil. 2016 Mar 30.
Outcomes and Lessons Learned From a Randomized Controlled Trial to Reduce Health Care Utilization During the First Year After Spinal Cord Injury Rehabilitation: Telephone Counseling Versus Usual Care.
Mackelprang JL, Hoffman JM, Garbaccio C, Bombardier CH.
OBJECTIVES: To describe the outcomes and lessons learned from a trial of telephone counseling (TC) to reduce medical complications and health care utilization and to improve psychosocial outcomes during the first year after spinal cord injury rehabilitation. DESIGN: Single-site, single-blind, randomized (1:1) controlled trial comparing usual care plus TC with usual care (UC). SETTING: Two inpatient rehabilitation programs. PARTICIPANTS: Adult patients (N=168) discharged between 2007 and 2010. INTERVENTIONS: The TC group (n=85, 51%) received up to eleven 30- to 45-minute scheduled telephone calls to provide education, resources, and support. The UC group (n=83, 49%) received indicated referrals and treatment. MAIN OUTCOME MEASURES: The primary outcome was a composite of self-reported health care utilization and medical complications. Secondary outcomes were depression severity, current health state, subjective health, and community participation. RESULTS: No significant differences were observed between TC and UC groups in the primary or secondary psychosocial outcomes. CONCLUSIONS: This study had a number of strengths, but included potential design weaknesses. Intervention studies would benefit from prescreening participants to identify those with treatable problems, those at high risk for poor outcomes, or those with intentions to change target behaviors. Interventions focused on treatment goals and designed to work in collaboration with the participant's medical care system may lead to improved outcomes.

J Spinal Cord Med. 2016 Mar 4:1-9.
Changes in pain and quality of life in depressed individuals with spinal cord injury: does type of pain matter?
Richardson EJ, Brooks LG, Richards JS, Bombardier CH, Barber J, Tate D, Forchheimer MB, Fann JR.
OBJECTIVE: To examine the association of neuropathic and nociceptive pain severity and interference with quality of life (QoL) in persons with spinal cord injury (SCI) who underwent a randomized controlled 12-week trial of an antidepressant to treat depression. A secondary objective was to assess the effect of changes in pain on mobility and physical independence. DESIGN: Multivariable ANCOVA models controlling for relevant demographic covariates, treatment condition, and baseline pain and QoL were used. SETTING: Six rehabilitation centers. PARTICIPANTS: Of the 133 persons who were randomized into the trial, 108 provided pain severity and interference ratings through follow-up. INTERVENTIONS: Not applicable. OUTCOME MEASURES: The Satisfaction with Life Scale and the physical and mental component summary scores of the 12-Item Short-Form Health Survey (SF-12). Secondary outcome measures included the mobility and physical independence subscales of the Craig Handicap Assessment and Reporting Technique (CHART). RESULTS: Broadly, few associations between pain and QoL were evident. Results revealed relationships between lower baseline nociceptive pain interference and higher satisfaction with life and mental health-related QoL at 12 weeks. Similarly, lower neuropathic pain interference was associated with change in physical independence, but unrelated to mobility.CONCLUSIONS: Pain interference over time may be differentially related to QoL outcomes based on the type of pain following SCI, but overall, there were no extensive relationships between pain and QoL in this sample of depressed persons with SCI

2015

Arch Phys Med Rehabil. 2015 Oct 22.
Depression Trajectories During the First Year After Spinal Cord Injury
Bombardier CH, Adams LM, Fann JR, Hoffman JM.
Little is known about the course of emotional adjustment after spinal cord injury. This study was conducted to determine the number and type ofdepression trajectories during the first year after SCI and to identify predictors of these trajectories. Data came from 141 acute SCI inpatients who enrolled in a randomized controlled trial telephone follow-up intervention, which showed no outcome differences, and completed depression and quality of life assessments on at least 2 of the 4 follow-up occasions (3, 6, 9, and 12 months after injury). Participants were on average 41 years old, most were male (81.6%), non-Hispanic (96%) and white (86%), and 61.7% had tetraplegia. Three trajectory groups emerged. Most participants fell into the “stable low depression” group (63.7%); 29.1% had “mild-moderate depression”; and 7.1% had “persistent moderate to severe depression,” which was primarily a continuation or relapse of pre-injury depression.  Preinjury mental health history and baseline pain, quality of life, and grief were predictors of which group an individual was likely to be in during the first year after injury. This information has potential for identifying individuals at risk for post-injury depression and providing timely interventions. 

J Spinal Cord Med. 2015 Jun 25:1-5.
Benefits of an exercise wellness program after spinal cord injury.
Crane DA, Hoffman JM, Reyes MR.
OBJECTIVE: To describe the initial benefits of a structured group exercise program on exercise frequency and intensity, perceived health, pain, mood, and television watching habits. DESIGN: Pre-test/post-test. PARTICIPANTS/METHODS: Eighty-nine persons with SCI participated voluntarily in a no-cost, twice weekly physical therapy group exercise class over 3 months. Forty-five persons completed pre- and post-participation interviews on exercise frequency and intensity, perceived health, pain, mood, sleep, and television watching habits. RESULTS: Mean participant age of the respondents was 43.82 years. 49% had AIS C or D injuries, 24% had AIS A, B paraplegia, 9% had AIS A,B C1-C4 and 18% had AIS A,B C5-C8. 75.6% of participants were male and 84.4% had a traumatic etiology as the cause of their SCI. There was a significant improvement in days of strenuous and moderate exercise as well as health state. There was an average decrease in pain scores, depression scores, number of hours spent watching television, and days/week of mild exercise. CONCLUSION: Participation in structured, small group exercise as a component of a wellness program after SCI shows promise for improving regular exercise participation and health state, but benefits may also occur across other areas of health and function including mood, pain, and hours spent watching television. Further follow-up is needed to determine whether improvements can be maintained after program completion and across all neurological levels.

Arch Phys Med Rehabil. 2015 Apr;96(4):680-9.
Efficacy of Venlafaxine XR for the Treatment of Pain in Patients With Spinal Cord Injury and Major Depression: A Randomized, Controlled Trial.
Richards JS, Bombardier CH, Wilson CS, Chiodo AE, Brooks L, Tate DG, Temkin NR, Barber JK, Heinemann AW, McCullumsmith C, Fann JR.
OBJECTIVES: To (1) determine the efficacy of venlafaxine XR for the treatment of pain (secondary aim) in individuals with spinal cord injury (SCI) enrolled in a randomized controlled trial (RCT) on the efficacy of venlafaxine XR for major depressive disorder (MDD) (primary aim); and (2) test the hypothesis that venlafaxine XR would be effective for both neuropathic and nociceptive pain. DESIGN: Multisite, double-blind, randomized (1:1) controlled trial with subjects block randomized and stratified by site, lifetime history of substance abuse, and prior history of MDD. SETTING: Six Departments of Physical Medicine and Rehabilitation in university-based medical schools. PARTICIPANTS: Individuals (N=123) with SCI and major depression between 18 and 64 years of age, at least 1 month post-SCI who also reported pain. INTERVENTION: Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. OUTCOME MEASURES: A 0-to-10 numeric rating scale for pain, pain interference items of the Brief Pain Inventory; 30% and 50% responders. RESULTS: The effect of venlafaxine XR on neuropathic pain was similar to that of placebo. However venlafaxine XR resulted in statistically significant and clinically meaningful reductions in nociceptive pain site intensity and interference even after controlling for anxiety, depression, and multiple pain sites within the same individual. For those who achieved a minimally effective dose of venlafaxine XR, some additional evidence of effectiveness was noted for those with mixed (both neuropathic and nociceptive) pain sites. CONCLUSIONS: Venlafaxine XR could complement current medications and procedures for treating pain after SCI and MDD that has nociceptive features. Its usefulness for treating central neuropathic pain is likely to be limited. Research is needed to replicate these findings and determine whether the antinociceptive effect of venlafaxine XR generalizes to persons with SCI pain without MDD.

Arch Phys Med Rehabil. 2015 Mar 3.
Distinguishing Grief From Depression During Acute Recovery From Spinal Cord Injury.
Klyce DW, Bombardier CH, Davis TJ, Hartoonian N, Hoffman JM, Fann JR, Kalpakjian CZ.
OBJECTIVE: To examine whether grief is a psychometrically sound construct that is distinct from depression in individuals who have recently sustained a spinal cord injury (SCI). DESIGN: Cross-sectional survey. SETTING: Inpatient rehabilitation units at 3 geographically diverse, university-affiliated medical centers. PARTICIPANTS: Patients with SCI (N=206) were recruited (163 men [79.1%]). Most patients were non-Hispanic whites (n=175 [85.0%]). Most patients sustained a cervical SCI (n=134 [64.4%]). Various injury etiologies were represented, with the majority being accounted for by falls (n=72 [31.5%]) and vehicle-related accidents (n=69 [33.5%]). The mean time since injury was 53.5±40.5 days. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: An adapted version of the 12-item structured clinical interview for Prolonged Grief Disorder was used to assess symptoms of grief, and the Patient Health Questionnaire-9 was used to measure depression. Demographic and injury-related data were also collected. RESULTS: A principal component analysis (with direct oblimin rotation) of the grief measure suggested a 2-component solution. The content of items loading on the separate components suggested 2 subscales: loss (6 items; Cronbach α=.810) and trauma (6 items; Cronbach α=.823). Follow-up principal component analyses including both grief and depression measures suggested clear differentiation of grief-related loss from depression. The prevalence of clinically significant levels of grief was low (6%), and levels of depression were consistent with previous findings related to inpatient rehabilitation (23.5%). CONCLUSIONS: The items used to assess grief symptoms in patients participating in inpatient rehabilitation for recently sustained SCI appear to capture a psychometrically reliable construct that is distinct from that of depression. Research is needed on the predictive validity of early grief symptoms after SCI and the relation of grief to other psychological constructs over time.

JAMA Psychiatry. 2015 Mar 1;72(3):247-58
Venlafaxine Extended-Release for Depression Following Spinal Cord Injury: A Randomized Clinical Trial.
Fann JR, Bombardier CH, Richards JS, Wilson CS, Heinemann AW, Warren AM, Brooks L, McCullum smith CB, Temkin NR, Warms C, Tate DG; for the PRISMS Investigators.
Depression is prevalent and associated with negative outcomes in individuals with spinal cord injury (SCI). Antidepressants are used routinely to treat depression, yet no placebo-controlled trials have been published in this population to our knowledge. Objective: To determine the efficacy and tolerability of venlafaxine hydrochloride extended-release (XR) for major depressive disorder (MDD) or dysthymic disorder in persons with chronic SCI. Design, Setting, and Participants: Multisite, randomized (1:1), double-blind, placebo-controlled Project to Improve Symptoms and Mood After SCI (PRISMS) trial. All research staff conducting screening, intervention, and outcome procedures were blinded to randomization status. We screened 2536 patients from outpatient clinics at 6 SCI treatment centers in the United States and randomized 133 participants into the trial. Participants were 18 to 64 years old and at least 1 month after SCI, with MDD or dysthymic disorder. Seventy-four percent of participants were male, and participants were on average 40 years old and 11 years after SCI. Forty-seven percent had cervical injuries, 53.4% had American Spinal Injury Association injury severity A (complete injury) SCI, 24.1% had at least 2 prior MDD episodes, and 99.2% had current MDD. Common comorbidities included chronic pain (93.9%), significant anxiety (57.1%), and history of substance dependence (44.4%). Interventions:  Twelve-week trial of venlafaxine XR vs placebo using a flexible-dose algorithm. Main Outcomes and Measures:  The Hamilton Depression Rating Scale (HAM-D 17-item version and Maier subscale, which focuses on core depression symptoms and excludes somatic symptoms) over 12 weeks. Results: Mixed-effects models revealed a significant difference between the venlafaxine XR and placebo groups in improvement on the Maier subscale from baseline to 12 weeks (treatment effect, 1.6; 95% CI, 0.3-2.9; P = .02) but not on the HAM-D 17-item version (treatment effect, 1.0; 95% CI, -1.4 to 3.4; P = .42). Participants receiving venlafaxine XR reported significantly less SCI-related disability on the Sheehan Disability Scale at 12 weeks compared with placebo (treatment effect, 4.7; 95% CI, 1.5-7.8; P = .005). Blurred vision was the only significantly more common new or worsening adverse effect in the venlafaxine XR group compared with the placebo group over 12 weeks. Conclusions and Relevance: Venlafaxine XR was well tolerated by most patients and an effective antidepressant for decreasing core symptoms of depression and improving SCI-related disability. Further research is needed to determine the optimal treatment and measurement approaches for depression in chronic SCI.

Arch Phys Med Rehabil. 2015 May;96(5):799-808.
Novel risk factors associated with current suicidal ideation and lifetime suicide attempt in individuals with spinal cord injury.
McCullumsmith CB, Kalpazian C, Richards JS, Forchheimer M, Heinemann A, Richardson E, Wilson C, Barber J, Temkin N, Fann JR, Bombardier CH; PRISMS Investigators.
OBJECTIVE: To determine unique associations for suicidal ideation and historical suicide attempts among individuals with spinal cord injury (SCI). DESIGN: Cross-sectional analysis SETTING: Outpatient PARTICIPANTS: 2,533 individuals with SCI 18 years or older with a history of traumatic SCI. INTERVENTIONS: None MAIN OUTCOME MEASURES: Any suicidal ideation in the prior 2 weeks (PHQ-9 item; SI) and any historical suicide attempt (SA). RESULTS: 323 (13.3%) reported SI in the prior 2 weeks and 179 (7.4%) reported historical SA. After controlling for other factors, both historical SA and current SI were associated with study site and current level of depression. Additionally, SA was associated with less education, younger age at injury, having current or prior treatment for depression, and having bipolar disorder or schizophrenia. SI was associated with more years since injury and previous SA. Several psychological factors were associated with current SI and historical SAs, including lower environmental reward and less positive affect. Additionally, control of one's community activities and spiritual well-being were associated with current SI. Severity of SCI also was associated in bivariate comparisons with the 47% of the SAs which occurred after injury. CONCLUSION: Several unique associations for SI and historical SA in individuals with SCI were identified, including level of environmental reward and control, spiritual well-being and severity of SCI. These factors bear further investigation as prospective risk factors for suicidal behavior after SCI.

2014

J Spinal Cord Med. 2014 Nov;37(6):672-92.
Adverse events in cardiovascular-related training programs in people with spinal cord injury: A systematic review.
Warms CA, Backus D, Rajan S, Bombardier CH, Schomer KG, Burns SP.
CONTEXT: There are anecdotal reports of adverse events (AEs) associated with exercise in people with spinal cord injury (SCI) and consequent concern by people with SCI and their providers about potential risks of exercise. Enumeration of specific events has never been performed and the extent of risk of exercise to people with SCI is not understood. OBJECTIVE: To systematically review published evidence to identify and enumerate reports of adverse events or AEs associated with training in persons with SCI. METHODS: Review was limited to peer-reviewed studies published in English from 1970 to 2011: (1) in adults with SCI, (2) evaluating training protocols consisting of repeated sessions over at least 4 weeks to maintain or improve cardiovascular health, (3) including volitional exercise modalities and functional electrical stimulation (FES)-enhanced exercise modalities, and (4) including a specific statement about AEs. Trained reviewers initially identified  a total of 145 studies. After further screening, 38 studies were included in the  review. Quality of evidence was evaluated using established procedures. RESULTS: There were no serious AEs reported. There were no common AEs reported across most types of interventions, except for musculoskeletal AEs related to FES walking. There were few AEs in volitional exercise studies. CONCLUSION: There is no evidence to suggest that cardiovascular exercise done according to guidelines and established safety precautions is harmful. To improve the strength of these conclusions, future publications should include definition of AEs, information about pre-intervention screening, and statements of the nature and extent of AEs.

J Spinal Cord Med2014 Oct 9.
Examining health-care utilization in the first year following spinal cord injury.
Skelton F, Hoffman JM, Reyes M, Burns SP.
One hundred sixty-eight patients were enrolled and followed by telephone follow-up questionnaires at three, six, nine and 12 months after discharge from an SCI Model System inpatient rehabilitation (IR) program. Participants were grouped according to the American Spinal Cord Injury Association (ASIA) impairment scale (AIS): C1-4, AIS A-C; C5-C8 AIS A-C, paraplegia AIS A-C, and all AIS D. This study looked at how much hospital care, outpatient visits, and home services the participants used during the first year after IR. Forty-five percent of subjects were hospitalized in the first year. Twenty percent were initially discharged to a skilled nursing facility (SNF), and an additional 10% required SNF care during the first year. Overall, those with C1-4 AIS A-C used the most health care services. Participants discharged home after IR used less health care than those who went elsewhere after discharge. Individuals who had SCI due to falls needed fewer in-home service visits than those who were injured in vehicular crashes. Age, sex, race, and education were unrelated to higher use. The authors conclude that focusing on reducing genitourinary and respiratory complications may reduce the need for hospital care in the first year after IR.

Arch Phys Med Rehabil. 2014 Oct 22.
Differences in Quality of Life Outcomes among Depressed Spinal Cord Injury Trial Participants.
Tate DG, Forchheimer M, Bombardier CH, Heinemann AW, Neumann HD, Fann JR.
OBJECTIVE: To assess the role that treatment response plays in a randomized clinical trial of an anti-depressant among people with spinal cord injury (SCI) diagnosed with major depression disorder (MDD) in explaining quality of life (QOL), assessed both globally as life satisfaction and in terms of physical and mental health-related QOL. DESIGN: Multivariable analyses were conducted, controlling for demographic, neurological and participatory factors as well as perceived functional limitations. SETTING: A 12-week randomized clinical trial of venlafaxine XR conducted at 6 centers around the U.S. PARTICIPANTS: 124 of the 133 persons who were randomized into the "Project to Improve Symptoms and Mood after Spinal Cord Injury" randomized clinical trial. All were between the ages of 18 and 64, at least one month post SCI, met the DSM IV criteria for MDD and completed the core measures used in this study. MAIN OUTCOME MEASURES: The Satisfaction with Life Scale and the SF-12's Physical and Mental Component Summary scores. RESULTS: Reduction in depressive symptoms over the course of a 12 week trial was predictive of increased QOL, measured as life satisfaction and mental well-being, within the context of other explanatory factors. Reduction in symptoms did not explain differences in physical well-being among those with MDD, however. Perceived functional disability, explained all three indices of QOL. CONCLUSIONS: Greater recognition has been given to QOL outcomes as endpoints of clinical trials as these often reflect participants' reported outcomes. Our findings support the association of QOL to reduction of depression symptoms among trial participants. This association differs depending upon how QOL is defined and measured, with stronger relationships observed with life satisfaction and mental well-being among those diagnosed with MDD. The lack of association between depression with physical well-being may be explained by participants' subjective interpretation of physical well-being following SCI, their expectations and perceptions of improved physical health related QOL based on the use of assistive technology. Consistent with our findings, pain is likely to play a role in decreasing physical QOL among those with incomplete injuries. The authors suggest caution in using physical well-being as an endpoint in trials among people with SCI.

J Spinal Cord Med. 2014 May;37(3):247-63.
A randomized controlled trial of venlafaxine XR for major depressive disorder after spinal cord injury: Methods and lessons learned.
Bombardier CH, Fann JR, Wilson CS, Heinemann AW, Richards JS, Warren AM, Brooks L, Warms CA, Temkin NR, Tate DG.
We describe the rationale, design, methods, and lessons learned conducting a treatment trial for major depressive disorder (MDD) or dysthymia in people with spinal cord injury (SCI). Design: A multi-site, double-blind, randomized (1:1) placebo controlled trial of venlafaxine XR for MDD or dysthymia. Subjects were block randomized and stratified by site, lifetime history of substance dependence, and prior history of MDD. Setting: Six SCI centers throughout the United States. Participants: Across participating centers, 2536 subjects were screened and 133 were enrolled into the trial. Subjects were 18–64 years old and at least 1 month post-SCI. Interventions: Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. Outcome measures: The primary outcome was improvement in depression severity at 12 weeks. The secondary outcome was improvement in pain. Results: This article includes study methods, modifications prompted by a formative review process, preliminary data on the study sample and lessons learned. We describe common methodological and operational challenges conducting multi-site trials and how we addressed them. Challenges included study organization and decision making, staff training, obtaining human subjects approval, standardization of measurement and treatment, data and safety monitoring, subject screening and recruitment, unblinding and continuity of care, database management, and data analysis. Conclusions: The methodological and operational challenges we faced and the lessons we learned may provide useful information for researchers who aim to conduct clinical trials, especially in the area of medical treatment of depression in people with SCI.

Spinal Cord. 2014 May;52(5):407-12.
Screening for neuropathic pain after spinal cord injury with the Spinal Cord Injury Pain Instrument (SCIPI): a preliminary validation study.
Bryce TN, Richards JS, Bombardier CH, Dijkers MP, Fann JR, Brooks  L, Chiodo A, Tate DG, Forchheimer M.
Study design: Cross-sectional. Objective: To preliminarily evaluate the validity of  an interview-based spinal cord injury (SCI) neuropathic pain screening instrument. Setting: Six university-based SCI centers in the United States. Methods: Clinician diagnoses of neuropathic pain (NP) and non-neuropathic pain subtypes were collected independently of descriptions of the pain characteristics provided by the persons with SCI by using the Spinal Cord Injury  Pain Instrument (SCIPI); SCIPI information and physician diagnoses for 82 pain sites of which they were most confident were subsequently compared. Results: Four of the SCIPI items correlated significantly with the NP subtype as determined by  the clinician. The best cutoff score for identifying NP was an endorsement of two or more of these four items. Using this cutoff, sensitivity of the SCIPI was 78%, specificity was 73% and overall diagnostic accuracy was 76%.Conclusion:In this preliminary study, the SCIPI, which can be administered by a nonclinician, appears to have good sensitivity, specificity and diagnostic accuracy in a SCI population; it may have a role as a screening tool for NP after SCI. Further study is needed.

Rehabil Psychol. 2014 Feb;59(1):50-6.
Identifying depression severity risk factors in persons with traumatic spinal cord injury.
Williams RT, Wilson CS, Heinemann AW, Lazowski LE, Fann JR, Bombardier CH; PRISMS Investigators.
Purpose/Objective: Examine the relationship between demographic characteristics,  health-, and injury-related characteristics, and substance misuse across multiple levels of depression severity. Research Method/Design: 204 persons with traumatic spinal cord injury (SCI) volunteered as part of screening efforts for a randomized controlled trial of venlafaxine extended release for major depressive  disorder (MDD). Instruments included the Patient Health Questionnaire-9 (PHQ-9) depression scale, the Alcohol Use Disorders Identification Test (AUDIT), and the  Substance Abuse in Vocational Rehabilitation-Screener (SAVR-S), which contains 3  subscales: drug misuse, alcohol misuse, and a subtle items scale. Each of the SAVR-S subscales contributes to an overall substance use disorder (SUD) outcome.  Three proportional odds models were specified, varying the substance misuse measure included in each model. Results: 44% individuals had no depression symptoms, 31% had mild symptoms, 16% had moderate symptoms, 6% had moderately severe symptoms, and 3% had severe depression symptoms. Alcohol misuse, as indicated by the AUDIT and the SAVR-S drug misuse subscale scores were significant predictors of depression symptom severity. The SAVR-S substance use disorder (SUD) screening outcome was the most predictive variable. Level of education was only significantly predictive of depression severity in the model using the AUDIT alcohol misuse indicator. Conclusions/Implications: Likely SUD as measured by the SAVR-S was most predictive of depression symptom severity in this sample of persons with traumatic SCI. Drug and alcohol screening are important for identifying individuals at risk for depression, but screening for both may be optimal. Further research is needed on risk and protective factors for depression, including psychosocial characteristics.

Top Spinal Cord Inj Rehabil. 2014 Winter;20(1):32-9.
Depression, pain intensity, and interference in acute spinal cord injury.
Cuff L, Fann JR, Bombardier CH, Graves DE, Kalpakjian CZ.
BACKGROUND: The high prevalence of pain and depression in persons with spinal cord injury (SCI) is well known. However the link between pain intensity, interference, and depression, particularly in the acute period of injury, has not received sufficient attention in the literature. OBJECTIVE: To investigate the relationship of depression, pain intensity, and pain interference in individuals undergoing acute inpatient rehabilitation for traumatic SCI. METHODS: Participants completed a survey that included measures of depression (PHQ-9), pain intensity ("right now"), and pain interference (Brief Pain Inventory: general activity, mood, mobility, relations with others, sleep, and enjoyment of life). Demographic and injury characteristics and information about  current use of antidepressants and pre-injury binge drinking also were collected. Hierarchical multiple regression was used to test depression models in 3 steps: (1) age, gender, days since injury, injury level, antidepressant use, and pre-injury binge drinking (controlling variables); (2) pain intensity; and (3) pain interference (each tested separately). RESULTS: With one exception, pain interference was the only statistically significant independent variable in each of the final models. Although pain intensity accounted for only 0.2% to 1.2% of the depression variance, pain interference accounted for 13% to 26% of the variance in depression. CONCLUSION: Our results suggest that pain intensity alone is insufficient for understanding the relationship of pain and depression in acute SCI. Instead, the  ways in which pain interferes with daily life appear to have a much greater bearing on depression than pain intensity alone in the acute setting.

Arch Phys Med Rehabil. 2014 Jun;95(6):1106-13
Predictors of Participation Enfranchisement following Spinal Cord Injury: The Mediating Role of Depression and Moderating Role of Demographic and Injury Characteristics.
Wong AW, Heinemann AW, Wilson CS, Neumann H, Fann JR, Tate DG,  Forchheimer M, Richards JS, Bombardier CH.
OBJECTIVES: (1) To examine the mediating effects of depressive symptoms on the relationships between employment, grief, depression treatment, and participation  enfranchisement following spinal cord injury (SCI), and (2) to examine the moderating role of demographic and injury characteristics including gender, race, marital status, education, and injury level and completeness on these relationships. DESIGN: Cross-sectional survey design as part of the Project to Improve Symptoms  and Mood after SCI (PRISMS). SETTING: Five rehabilitation facilities participating in the PRISMS study. PARTICIPANTS: Persons with SCI (N=522) enrolled from 2007 to 2011. Participants were an average of 42 years old, 76% male, 64% white, and 64% completed at least  a high school education. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Participation enfranchisement. RESULTS: The final model fit the data relatively well (CFI= 0.939, TLI= 0.894, RMSEA = 0.066, 90% CI: 0.043-0.089), explaining 32% of the variance in participation enfranchisement. Enfranchisement was positively related to employment and negatively related to depression. Grieving the loss of a loved one and use of an antidepressant or psychotherapy were related to participation enfranchisement; these relationships were mediated by depressive symptoms. Multi-group analyses supported the model's invariance across gender, marital status, severity of injury, and level of injury. CONCLUSIONS: Depression appears to mediate the influence of employment, grief, and depression treatments on participation enfranchisement following SCI. These relationships are applicable regardless of gender, marital status, and injury completeness and level. These findings highlight efforts to improve the detection and treatment of depression in SCI rehabilitation programs that may enhance participation.

J Spinal Cord Med. 2014 Mar;37(2):218-25.
Post-traumatic growth following spinal cord injury.
Kalpakjian CZ, McCullumsmith CB, Fann JR, Richards JS, Stoelb BL, Heinemann AW, Bombardier CH.
Context/objective Examine the relationship of post-traumatic psychological growth (PTG), depression, and personal and injury characteristics in persons with spinal cord injury (SCI). Design Cross-sectional survey. Setting Community. Participants Eight hundred and twenty-four adults with SCI. Interventions None. Outcome measures Five items from the Post-traumatic Growth Inventory, reflecting positive change after injury in life priorities, closeness to others, new opportunities being available, stronger faith, and personal strength. Results Initial structural equation model testing of a conceptual model of personal and injury characteristics, violent etiology, depression, and PTG resulted in a poor fit. Model modifications resulted in an improved fit, but explained only 5% of the variance in PTG. Being female, younger, having less formal education, and less time since injury had significant relationships with PTG, whereas depression, violent etiology, and injury level/severity did not. In each PTG domain, between  54 and 79% of the sample reported at least some positive change after injury. Conclusions The results of this study, while promising, explained only a small portion of the variance in PTG. A majority of the sample experienced some positive change after injury, with the greatest change in discovering that they were stronger than they thought they were. Comparing means previously reported in a non-SCI sample of those who experienced trauma, positive change after injury was comparable for each PTG item except for new opportunities being available, which was significantly lower for those with SCI. Future directions of research include the development of theoretical models of PTG after SCI.

Arch Phys Med Rehabil. 2014 Mar;95(3):455-65.
Evaluating a spinal cord injury-specific model of depression and quality of life.
Hartoonian N, Hoffman JM, Kalpakjian CZ, Taylor HB, Krause JK, Bombardier CH.
OBJECTIVES: To determine whether demographic, injury, health, and functional factors similarly have the same predictive relation with both somatic and nonsomatic symptoms of depression, as well as whether somatic and nonsomatic symptoms of depression have the same association with quality of life (QOL). DESIGN: Secondary analysis of cross-sectional survey data. SETTING: Community PARTICIPANTS: Patients with traumatic spinal cord injury (N=4976) who completed an interview at 1 year postinjury between 2006 and 2011. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Somatic and nonsomatic symptoms of depression from the Patient Health Questionnaire-9 and QOL measured by the Satisfaction With Life Scale. RESULTS: Structural equation modeling showed that the hypothesized model provided a good fit to the data, but modification of the model led to a significant improvement in model fit: Δχ(2)(1)=226.21, P<.001; comparative fit index=.976; χ(2)(199)=585.39, P<.001; root mean square error of approximation=.027 (90% confidence interval, .025-.030). The health-related factors including pain severity, pain interference, and health status were similarly associated with both somatic and nonsomatic symptoms of depression. QOL was negatively associated with nonsomatic symptoms of depression but was unrelated to somatic symptoms of depression. CONCLUSIONS: Assessment of depression after spinal cord injury should include a careful assessment of health concerns given the relation between health-related factors and both somatic and nonsomatic symptoms of depression. Treatments of depressive symptoms may be improved by targeting health concerns, such as pain, along with a specific focus on nonsomatic symptoms to improve the QOL.

2013

Arch Phys Med Rehabil. 2013 Dec;94(12):2389-95.
Depression treatment preferences after acute traumatic spinal cord injury.
Fann JR, Crane DA, Graves DE, Kalpakjian CZ, Tate DG, Bombardier CH.
OBJECTIVE: To examine preferences for depression treatment modalities and settings and predictors of treatment preference in persons with spinal cord injury (SCI). DESIGN: Cross-sectional surveys. SETTING: Rehabilitation inpatient services. PARTICIPANTS: Persons with traumatic SCI (N=183) undergoing inpatient rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Patient Health Questionnaire-9 depression scale, history of psychiatric diagnoses and treatments, and a depression treatment preference survey. RESULTS: Among inpatients with SCI (28% had Patient Health Questionnaire-9 score  ≥10 indicating probable major depression), a physical exercise program was the most preferred treatment option (78% somewhat or very likely to try) followed by  antidepressants prescribed by a primary care provider (63%) and individual counseling in a medical or rehabilitation clinic (62%). All modalities were preferred over group counseling. Although not statistically significant, more depressed individuals stated a willingness to try antidepressants and counseling  than nondepressed individuals. Subjects preferred treatment in a medical/rehabilitation setting over a mental health setting. Those with a prior diagnosis of depression and a history of antidepressant use were significantly more willing to take an antidepressant. Age ≥40 years was a significant predictor of willingness to receive individual counseling. CONCLUSIONS: Treatment preferences and patient education are important factors when choosing a depression treatment modality for patients with SCI. The results suggest that antidepressants, counseling, and exercise may be promising components of depression treatment in this population, particularly if they are integrated into medical or rehabilitation care.

Arch Phys Med Rehabil. 2013 Nov 19
Evaluating a Spinal Cord Injury-Specific Model of Depression and Quality of Life.
Hartoonian N, Hoffman JM, Kalpakjian CZ, Taylo HB, Krause JK, Bombardier CH.
OBJECTIVE: To determine whether demographic, injury, health, and functional factors similarly have the same predictive relationship with both somatic and non-somatic symptoms of depression, as well as whether somatic and non-somatic symptoms of depression have the same association with quality of life (QOL). DESIGN: Secondary analysis of cross-sectional survey data. SETTING: SCI Model Systems ational Database. PARTICIPANTS: 4976 participants with traumatic SCI who completed an interview at 1-year post injury between 2006 and 2011. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Somatic and non-somatic symptoms of depression from the Patient Health Questionnaire-9 and quality of life measured by the Satisfaction With Life Scale (SWLS). RESULTS: Structural equation modeling (SEM) showed that the hypothesized model provided a good fit to the data, but modification of the model lead to a significant improvement in model fit, Δχ2(1) = 226.21, p < .001; CFI = .976; χ2(199) = 585.39, p < .001; RMSEA = .027 (90% C.I.: .025 - .030). The health-related factors including pain severity, pain interference, and health status were similarly associated with both somatic and non-somatic symptoms of depression. Quality of life was negatively associated with non-somatic symptoms of depression, but was unrelated to somatic symptoms of depression. CONCLUSIONS: Assessment of depression after SCI should include a careful assessment of health concerns given the relationship between health-related factors and both somatic and non-somatic symptoms of depression. Treatments for depressive symptoms may be improved by targeting health concerns, such as pain, along with a specific focus on non-somatic symptoms in order to improve QOL.

J Spinal Cord Med. 2013 Jun 26.
A randomized controlled trial of venlafaxine XR for major depressive disorder after spinal cord injury: Methods and lessons learned.
Bombardier CH, Fann JR, Wilson CS, Heinemann AW, Richards JS, Warren AM, Brooks L, Warms CA, Temkin NR, Tate DG.
Context/objective: We describe the rationale, design, methods, and lessons learned conducting a treatment trial for major depressive disorder (MDD) or dysthymia in people with spinal cord injury (SCI).DESIGN: A multi-site, double-blind, randomized (1:1) placebo controlled trial of venlafaxine XR for MDD or dysthymia. Subjects were block randomized and stratified by site, lifetime history of substance dependence, and prior history of MDD. SETTING: Six SCI centers throughout the United States. PARTICIPANTS: Across participating centers, 2536 subjects were screened and 133 were enrolled into the trial. Subjects were 18-64 years old and at least 1 month  post-SCI. INTERVENTIONS: Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. OUTCOME MEASURES: The primary outcome was improvement in depression severity at 12 weeks. The secondary outcome was improvement in pain. RESULTS: This article includes study methods, modifications prompted by a formative review process, preliminary data on the study sample and lessons learned. We describe common methodological and operational challenges conducting  multi-site trials and how we addressed them. Challenges included study organization and decision making, staff training, obtaining human subjects approval, standardization of measurement and treatment, data and safety monitoring, subject screening and recruitment, unblinding and continuity of care, database management, and data analysis. CONCLUSIONS: The methodological and operational challenges we faced and the lessons we learned may provide useful information for researchers who aim to conduct clinical trials, especially in the area of medical treatment of depression in people with SCI.

Arch Phys Med Rehabil. 2013 Apr;94(4):731-6.
Self-reported depression and physical activity in adults with mobility impairments.
Rosenberg DE, Bombardier CH, Artherholt S, Jensen MP, Motl RW.
OBJECTIVE:  To test hypothesized associations between depression and physical activity among adults with multiple sclerosis (MS), spinal cord injury (SCI), muscular dystrophy (MD), and postpolio syndrome (PPS). DESIGN:  Cross-sectional survey. SETTING:  Survey responses collected from individuals in the Washington state area (participants with SCI) and across the United States (participants with MS, MD, and PPS). PARTICIPANTS:  Convenience sample of participants were surveyed (N=1676; MD, n=321; PPS, n=388; MS, n=556; SCI, n=411). INTERVENTIONS:  Not applicable. MAIN OUTCOME MEASURES:  The Patient Health Questionnaire-9 (PHQ-9) assessing depressive symptoms and the International Physical Activity Questionnaire (IPAQ) and Godin Leisure Time Exercise Questionnaire (GLTEQ) assessing physical activity. RESULTS:  The average age was 56 years, 64% were women, 92% were white, 86% had a high school degree or higher, and 56% walked with an assistive device or had limited self-mobility. The IPAQ and GLTEQ explained a small but statistically significant and unique amount of the variance in PHQ-9 scores in all diagnostic groups, with no significant differences in the relation by condition, age, or mobility status (IPAQ R(2)=.004; GLTEQ R(2)=.02; both P<.02). CONCLUSIONS:  Both physical activity measures demonstrated a small but statistically significant association with depression in all 4 diagnostic groups. Research is needed to determine longitudinal relations and whether physical activity interventions could promote improved mood in adults with physical disabilities.

2012

Am J Phys Med Rehabil. 2012 Aug;91(8):640-51.
Perceived exercise self-efficacy as a predictor of exercise behavior in individuals aging with spinal cord injury.
Kroll T, Kratz A, Kehn M, Jensen MP, Groah S, Ljungberg IH, Molton IR, Bombardier C.
OBJECTIVE: The purpose of this study was to test the hypothesized association between exercise self-efficacy and exercise behavior, controlling for demographic variables and clinical characteristics, in a sample of individuals with spinal cord injuries. DESIGN: A cross-sectional national survey of 612 community-dwelling adults with spinal cord injury in the United States ranging from 18 to 89 yrs of age was conducted. Sample consisted of 63.1% men with a mean (SD) duration of 15.8 (12.79) yrs postinjury; 86.3% reported using a wheelchair. RESULTS: Self-efficacy was the only independent variable that consistently predicted all four exercise outcomes. Self-efficacy beliefs were significantly related to frequency and intensity of resistance training (R(2) change = 0.08 and 0.03, respectively; P < 0.01 for all) and aerobic training (R(2) change = 0.07 and 0.05, respectively; P < 0.01 for all), thus explaining between 3% and 8% of the variance. Hierarchical linear regression analysis revealed that controlling for other demographic and physical capability variables, the age-related variables made statistically significant contributions and explained between 1% and 3% of the variance in aerobic exercise frequency and intensity (R(2) change = 0.01 and 0.03, respectively; P < 0.01 for all). Clinical functional characteristics but not demographic variables explained participation in resistance exercise. CONCLUSIONS: Self-efficacy beliefs play an important role as predictors of exercise. Variations in exercise intensity along the age continuum have implications for exercise prescription and composition. Future research should replicate findings with objective activity measures.

J Spinal Cord Med. 2012 Jul;35(4):240-50.
Potentially modifiable risk factors among veterans with spinal cord injury hospitalized for severe pressure ulcers: a descriptive study.
Guihan M, Bombardier CH.
CONTEXT/OBJECTIVE:  Pressure ulcers (PrUs) are a serious, costly and potentially life-long complication of spinal cord injury (SCI). Co-morbid conditions increase PrU risk, adding to the health behavior challenges faced by people with SCI. Little is known about medical co-morbidities, health beliefs, risk, protective behaviors, and readiness to improve skin care behaviors in people with SCI. This study describes the potentially modifiable medical and behavioral risk factors among veterans with SCI and severe (Stage III/IV) PrUs. DESIGN:  Cross-sectional observational design. SETTING:  6 VA SCI Centers. PARTICIPANTS:  Convenience sample from a larger intervention study of 148 veterans hospitalized for PrUs. INTERVENTIONS:  Not applicable. OUTCOME MEASURES:  Knowledge, PrU risk, skin protective behaviors, health beliefs, and practices, health locus of control, skin worsening. RESULTS:  Most ulcers were stage IV (73%) and about half had 2+ PrUs. Participants reported a mean of 6.7 co-morbid conditions (respiratory, gastrointestinal, renal disease/urinary tract infection, autonomic dysreflexia, diabetes, bowel/bladder incontinence). Potential intervention opportunities include proactive assistance with management of multiple chronic conditions, substance abuse, nutrition, adherence to skin protective behaviors, readiness to change, and access to resources. Overall knowledge about PrUs was low, especially for how to prevent PrUs and what to do if skin breakdown occurs. CONCLUSION:  Future research should address whether comprehensive models that include patient self-management, decision support and health care system, and proactive behavior change assistance for patients help reduce PrU incidence and recurrence in persons with SCI.

Arch Phys Med Rehabil. 2012 Apr 30.
Validity of the Patient Health Questionnaire-9 in Assessing Major Depressive Disorder During Inpatient Spinal Cord Injury Rehabilitation
Charles H. Bombardier, PhD, Claire V. Kalpakjian, PhD, Daniel E. Graves, PhD, Joshua R. Dyer, PhD, Denise G. Tate, PhD, Jesse R. Fann, MD
Objective: To investigate the validity of the Patient Health Questionnaire-9 (PHQ-9) depression screening measure in people undergoing acute inpatient rehabilitation for spinal cord injury (SCI). Design: We performed a blinded comparison of the PHQ-9 administered by research staff with the major depression module of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) conducted by a mental health professional. Setting: Inpatient rehabilitation units. Participants: Participants (N_142) were patients undergoing acute rehabilitation for traumatic SCI who were at least 18 years of age, English speakers, and without severe cognitive, motor speech, or psychotic disorders. We obtained the SCID on 173 (84%) of 204 eligible patients. The final sample of 142 patients (69%) consisted of those who underwent both assessments within 7 days of each other. Interventions: Not applicable. Main Outcome Measures: PHQ-9 and SCID major depression module. Results: Participants were on average 42.2 years of age, 78.2% men, and 81.7% white, and 66.9% had cervical injuries. The optimal PHQ-9 cutoff (_11) resulted in 35 positive screens (24.6%). Key indices of criterion validity were as follows: sensitivity, 1.00 (95% confidence interval [CI], .73- 1.00); specificity, .84 (95% CI, .76 -.89); Youden Index, .84; positive predictive value, .40 (95% CI, .24 -.58); and negative predictive value, 1.00 (95% CI, .96 -1.00). The area under the receiver operator curve was .92, and _ was .50. Total PHQ-9 scores were inversely correlated with subjective health state and quality of life since SCI. Conclusions: The PHQ-9 meets criteria for good diagnostic accuracy compared with a structured diagnostic assessment for major depressive disorder even in the context of inpatient rehabilitation for acute traumatic SCI.

Arch Phys Med Rehabil 2012;93(5):775-781.
An Exploration of Modifiable Risk Factors for Depression After Spinal Cord Injury: Which Factors Should We Target?
Charles H. Bombardier, Jesse R. Fann, Denise G. Tate, J. Scott Richards, Catherine S. Wilson, Ann Marie Warren, Nancy R. Temkin, Allen W. Heinemann.
Objective:
To identify modifiable risk factors for depression in people with spinal cord injury (SCI). Design: Cross-sectional survey. Setting: Outpatient and community settings. Participants: Community-residing people with SCI (N=244; 77% men, 61% white; mean age, 43.1y; 43% with tetraplegia) who were at least 1 month postinjury. Interventions: Not applicable. Main Outcome Measures: Depression severity (Patient Health Questionnaire-9 [PHQ-9]), physical activity (International Physical Activity Questionnaire [IPAQ]), pleasant and rewarding activities (Environment Rewards Observation Scale [EROS]), and self-efficacy to manage the effects of SCI (Modified Lorig Chronic Disease Self-Management Scale). Results: Greater depression severity was associated with being 20 to 29 years of age, not completing high school, not working or attending school, and being <4 years post-SCI. After controlling for demographic and injury characteristics (adjustedR2=.13), lower EROS scores (change in adjusted R2=.34) and lower self-efficacy (change inR2=.13) were independent predictors of higher PHQ-9 scores. Contrary to predictions, physical activity as measured by the IPAQ did not predict depression severity. Conclusions: Our findings suggest that having fewer rewarding activities, and to a lesser extent, having less confidence in one’s ability to manage the effects of SCI are independent predictors of greater depression severity after SCI. Interventions such as behavior activation, designed to increase rewarding activities, may represent an especially promising approach to treating depression in this population.

Abstracts of NWRSCIS articles published during the 2006-2011 grant cycle

2011

Journal of Spinal Cord Medicine 2011 September;34(5):461-472
Preinjury alcohol and drug use among persons with spinal cord injury: Implications for rehabilitation
Michael W. Stroud, Charles H. Bombardier, Joshua R. Dyer, Carl T. Rimmele, Peter C. Esselman.
Objective: To describe preinjury alcohol and drug use and opportunities for secondary prevention among persons with recent spinal cord injury (SCI). Design: Survey. Setting: Acute inpatient rehabilitation program. Participants: Participants were 118 (84.8%) of 139 consecutive admissions who met inclusion criteria and were screened for preinjury alcohol and drug use. Interventions: None. Outcome measures: Alcohol and drug use, toxicology results, alcohol problems, readiness to change, and treatment preferences. Results: Participants were on average 37 years old, 84% were men, and 85% were white. Fifty-one percent of the sample was considered 'at-risk' drinkers. Significant lifetime alcohol-related problems were reported by 38% of the total sample. Thirty-three percent reported recent illicit drug use and 44% of the 82 cases with toxicology results were positive for illicit drugs. Seventy-one percent of at-risk drinkers reported either considering changes in alcohol use or already taking action. Forty-one percent reported interest in trying substance abuse treatment or Alcoholics Anonymous (AA). Motivation to change alcohol use was significantly and positively associated with self-reported indicators of alcohol problem severity. Conclusion: Preinjury alcohol and drug abuse are common among persons with recent SCI. Substance abuse screening is feasible and detects not only salient clinical problems but also significant motivation to change and interest in AA or treatment, all of which represent an important window of opportunity for appropriate brief interventions and referrals. In contrast with the idea that alcoholism is a 'disease of denial', the majority of atrisk drinkers with new onset SCI indicate they are considering making changes.

Topics in Spinal Cord Injury Rehabilitation, Volume 17(2) , Pgs. 46-58
Postrehabilitative health care for individuals with SCI: Extending health care into the community.
DeJong G, Hoffman J, Meade MA, Bombardier C, Deutsch A, Nemunaitis G, Roach MJ, Tate DG, Boninger ML, Chen Y, Hsieh J, Jette A, Wierbicky J, Chiodo A, Forchheimer M.
Article outlines challenges that individuals with spinal cord injury (SCI) face and documents potential solutions to better meet their ongoing post-rehabilitation health care needs. The post-rehabilitation health challenges facing individuals with SCI fall into 2 very broad categories: access to primary care and related health services and issues related to health plan coverage and payment. Over the last few decades, 3 sets of solutions have emerged to answer these problems: patient education and health behavior change, better transitions from rehabilitation care to community health care, and new systems of health care delivery customized to the needs of individuals with disabilities. The authors examine each of these strategies, their current state of development, and their implications for future developments in post-rehabilitation health care for individuals with SCI. 

Journal of Spinal Cord Medicine, 2011 July;34(4):404-409(6)
Use of on-demand video to provide patient education on spinal cord injury
Hoffman JM, Salzman CJ, Garbaccio CJ, Bombardier CH.
Background/objective: Persons with chronic spinal cord injury (SCI) have a high lifetime need for ongoing
patient education to reduce the risk of serious and costly medical conditions. We have addressed this need
through monthly in-person public education programs called SCI Forums. More recently, we began
videotaping these programs for streaming on our website to reach a geographically diverse audience of
patients, caregivers, and providers. Design/methods: We compared information from the in-person forums to that of the same forums shown streaming on our website during a 1-year period. Results: Both the in-person and Internet versions of the forums received high overall ratings from individuals who completed evaluation forms. Eighty-eight percent of online evaluators and 96% of in-person evaluators reported that they gained new information from the forum; 52 and 64% said they changed their attitude, and 61 and 68% said they would probably change their behavior or take some kind of action based on information they learned. Ninety-one percent of online evaluators reported that video is better than text for presenting this kind of information.
Conclusion: Online video is an accessible, effective, and well-accepted way to present ongoing SCI education
and can reach a wider geographical audience than in-person presentations.

Journal of Aging Research. 2011:708510
Physical Activity Among Persons Aging with Mobility Disabilities: Shaping a Research Agenda
Rosenberg DE, Bombardier CH, Hoffman JM, Belza B.
With the aging of the baby boomer population and their accompanying burden of disease, future disability rates are expected to increase. This paper summarizes the state of the evidence regarding physical activity and aging for individuals with mobility disability and proposes a healthy aging research agenda for this population. Using a previously published framework, we present evidence in order to compile research recommendations in four areas focusing on older adults with mobility disability: (1) prevalence of physical activity, (2) health benefits of physical activity, (3) correlates of physical activity participation, and, (4) promising physical activity intervention strategies. Overall, findings show a dearth of research examining physical activity health benefits, correlates (demographic, psychological, social, and built environment), and interventions among persons aging with mobility disability. Further research is warranted.

PM&R. 2011 Jun;3(6):533-40.
Confirmatory factor analysis of the patient health questionnaire-9: a study of the participants from the spinal cord injury model systems.
Krause JS, Saunders LL, Bombardier C, Kalpakian C.
OBJECTIVE: To examine the factor structure of the Patient Health Questionnaire-9, a measure of depression, in persons with spinal cord injury (SCI). DESIGN: Cross-sectional, confirmatory factor analytic study. SETTING: Community. PARTICIPANTS: Data for 7296 persons with an SCI who had sustained their injury at least 1 year prior to assessment and who had complete Patient Health Questionnaire-9 data collected at a follow-up interview were drawn from the National Spinal Cord Injury Statistical Center Database. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Factor structure of the Patient Health Questionnaire-9. RESULTS: Confirmatory factor analysis indicated a marginal fit for the single factor solution (root mean square error of approximation [RMSEA] = 0.086), whereas the solution with 5 somatic items and 4 nonsomatic items had the best fit (RMSEA = 0.054) among 2-factor models that used all 9 items. Of the models that used fewer than 9 items, the best fit was for the 6-item solution with 3 somatic items (sleep, appetite, and fatigue) and 3 nonsomatic items (feeling down, feeling bad about self, and suicidal ideation; RMSEA = 0.043). Similar results were found across the strata except for the Hispanic group (for whom no model fit well). CONCLUSIONS: Given the results of this analysis that support a 2-factor structure of the Patient Health Questionnaire-9 in persons with SCI, the next step in this line of research is to validate each of these dimensions against other ways of measuring depression.

Arch Phys Med Rehabil 2011;92(3):352-360.
Depression After Spinal Cord Injury: Comorbidities, Mental Health Service Use, and Adequacy of Treatment
Fann JR, Bombardier CH, Richards JS, Tate DG, Wilson CS, Temkin N.
A sample of 947 community dwelling people with spinal cord injury (SCI) were recruited from 4 SCI Model Systems between 2007 and 2009. Subjects completed measures of depression and subjective health and provided information about medications, psychiatric history, and mental health treatment. Results: There was a 23% prevalence of probable major depression (PHQ-9 score ≥10). Those reporting depression indicated a greater history of anxiety, panic, or posttraumatic stress disorders. In depressed participants, 29% currently were receiving any antidepressant and 11% were receiving guideline-level antidepressant dose and duration, whereas 11% had been receiving any psychotherapy in the past 3 months and 6% had been receiving guideline-level psychotherapy in the past 3 months. Serotonergic antidepressants and individual psychotherapy were the most common types of treatment received. There was a wide range of provider types and treatment settings and these were not associated with mental health services or care. Conclusion: This study highlights the high prevalence of depression in people with SCI and documents for the first time the large gap in depression treatment in this population. These findings support the need for improved mental health care for persons with SCI and depression.

Arch Phys Med Rehabil 2011;92(3):411-418.
A longitudinal study of depression from 1 to 5 years after spinal cord injury.
Hoffman JM, Bombardier CH, Graves DE, Kalpakjian CZ, Krause JS.
The authors analyzed a sample of 1,035 participants in the SCI Model Systems national data set who completed 1 and 5-year postinjury follow-up interviews from 2000 to 2009. Results: Probable major depression (a score of 10 or higher on the PHQ-9 questionnaire measuring symptoms and severity of depression ) was found in 21% of participants at year 1 and 18% at year 5. Similar numbers of participants had improvement (25%) or worsening (20%) of symptoms over time, with 8.7% depressed at both 1 and 5 years. Increased pain, worsening health status, and decreasing unsafe use of alcohol (vs no unsafe use of alcohol) are risk factors for the development of depression at 5 years. No predictors of improvement in depression were found. Conclusion: To address this high prevalence, clinicians should use these risk factors and ongoing systematic screening to identify those at risk for depression. Worsening health problems and lack of effective depression treatment in participants with SCI may contribute to high rates of chronic or recurrent depression in this population.

Arch Phys Med Rehabil. 2011 Mar;92(3):457-63.
Mechanical ventilation, health, and quality of life following spinal cord injury.
Charlifue S, Apple D, Burns SP, Chen D, Cuthbert JP, Donovan WH, Lammertse DP, Meade MA, Pretz CR.
This is a prospective cross-sectional examination of 1,635 people with tetraplegia drawn from the SCI Model Systems National Database. Subjects were injured between 1994 and 2008 and completed a 1-year follow-up interview. Seventy-nine required at least some use of ventilator at discharge from rehabilitation. Results: Significant differences were found between the ventilator-user (VU) group and non-ventilator-user (NVU) group for cause of trauma, proportion with complete injury, neurologic impairment level, and number of rehospitalizations. The NVU group had significantly higher scores of measures of quality of life than the VU group and higher perceived health status compared with a year previously. They also had a lower incidence of depression than the VU group. There was no significant difference in perceived current health status between the two groups. Conclusions: People in this study who did not require mechanical ventilation at discharge from rehabilitation post-SCI reported generally better health and improved QOL compared with those who required ventilator assistance at 1 year postinjury. Nonetheless, the literature suggests that perceptions of QOL improve as people live in the community for longer periods.

Arch Phys Med Rehabil 2011;92(3): 369-375
Upper- and lower-extremity motor recovery after traumatic cervical spinal cord injury: an update from the national spinal cord injury database.
Marino RJ, Burns S, Graves DE, Leiby BE, Kirshblum S, Lammertse DP.
The purpose of this article was to report changes in American Spinal Injury Association Impairment Scale (AIS) grade, upper- (UEMS) and lower-extremity motor score (LEMS), and motor levels from injury up to 1 year postinjury in persons with traumatic tetraplegia included in the Spinal Cord Injury Model Systems (SCIMS) database and compare findings with those from the Sygen and EM-SCI databases. There were 1,436 subjects in this analysis, 80% were men, 44% injured by motor vehicle accident, 30% falls, 12% sports and 11% violence. Results: There were 22% subjects with AIS grade who converted to AIS grade B or better by rehabilitation discharge, and 30% by 1 year, with 8% to grade C and 7.1% to grade D. Motor level was unchanged or ascended in 35% and improved 1 level in 42%, 2 levels in 14% and more than 2 levels in 9%. Conclusion: More patients with cervical complete spinal cord injury may be converting to AIS grade D compared with earlier reports. Motor level recovery in those with AIS grade A and UEMS recovery in those with AIS grade C injuries are potential outcome measures for acute clinical trials.

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2010

Injury Prevention 2010;16:74-78.
Cost of spinal cord injuries caused by rollover automobile crashes.
Burns SP, Kaufman RP, Mack CD, Bulger E.
Objective: To determine the reduction in direct cost for treatment of spinal cord injuries (SCI) in belted occupants involved in rollover automobile crashes in the USA that would result if severe roof intrusion were eliminated. Methods: Risk of SCI per rollover crash and by belted/ unbelted status was calculated for roof intrusion magnitude categories using 1993-2006 National Automotive Sampling System Crashworthiness Data System (CDS) data. Direct costs of SCI based on neurological level and completeness of SCI were calculated using data from the National SCI Statistical Center. Results: A reduction in rate of SCI for belted occupants with >15 cm roof intrusion to the rate seen for belted occupants with 8-15 cm roof intrusion would reduce the direct cost of SCI by approximately $97 million annually. Conclusion: There would be substantial cost savings solely by a reduction in one uncommon type of injury, SCI, if severe roof intrusion were eliminated.

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2009

J Spinal Cord Med. 2009;32(2):147-56.
Patient health Questionnaire-9 in spinal cord injury: an examination of factor structure as related to gender.
Kalpakjian CZ, Toussaint LL, Albright KJ, Bombardier CH, Krause JK, Tate DG.
BACKGROUND/OBJECTIVE: Despite the attention depression after spinal cord injury (SCI) has received, research and clinical practice have been hampered by inadequate emphasis on reliable and valid measurement. Assessment of symptoms in persons with SCI is challenged by the presence of "trans-diagnostic" symptoms and unexamined effects of gender. The objective of this study was to examine the factor structure of the Patient Health Questionnaire-9 (PHQ-9; the 9-item depression scale of the Patient Health Questionnaire) and determine whether the structure replicates across gender. METHODS: A total of 1,168 women and men were matched on level/completeness of SCI, follow-up year, and age to create 584 pairs. Exploratory factor analysis examined 1- and 2-factor models and congruence in 2 randomly split half samples to establish congruence of the factor solution and replication across gender. RESULTS: The 1- and 2-factor solutions fit the structure of the items accounting for 41% to 51% of original item variance. Congruence between random samples was uniformly high for the 1-factor solution (r = 0.791-0.948) but variable for the 2-factor solution. Although congruence was high for the combined sample and men (r = 0.90-0.97 and 0.71-0.94, respectively), it was variable for women (r = 0.29-0.85). CONCLUSIONS: Although there was support for the 1-factor structure of the PHQ within and between sexes, the low congruence between sexes and within women for the 2-factor structure indicates potentially important differences about how certain symptoms may be experienced or interpreted differently, by men and women with SCI. Future research should focus on where sexes diverge in cognitive, affective, and somatic dimensions of depressive symptoms and whether sex-specific or sex-neutral measures are warranted.

Arch Phys Med Rehabil 2009;90:1668-71.
Hydrophilic catheters versus noncoated catheters for reducing the incidence of urinary tract infections: a randomized controlled trial.
Cardenas DD, Hoffman JM.  
Objective: To test the hypotheses that hydrophilic catheters reduce the incidence of symptomatic urinary tract infections (UTIs) in persons with spinal cord injury on self–intermittent catheterization (IC). Design: Randomized controlled trial. Setting: Community. Participants: Subjects (N_56) on IC with recurrent UTIs and who met eligibility criteria. Intervention: Use of hydrophilic catheters for IC. Main Outcome Measure: Symptomatic UTIs treated with antibiotics. Results: Of the 56 subjects enrolled, 45 completed the study (22 in the treatment group, 23 in the control group). There were no significant differences in demographics, including sex, between the treatment group and the controls except for more tetraplegic subjects in the control group (P_.05). Seventy-one percent of the treatment group and 52% of the control group were men. The total number of symptomatic UTIs treated with antibiotics was significantly smaller in the treatment group than in the control group (P_.05). Seventy percent of the control group had at least 1 antibiotic treatment episode compared with only 50% of those with the hydrophilic catheter (P_.18). There was no significant difference in the incidence of bacteriuria or symptomatic UTIs among the 2 groups. Level of injury and years with injury were unrelated to symptomatic UTIs, but being female increased the risk of UTIs (P_.01). Conclusions: Although there was no difference in the number of symptomatic UTIs in the 2 groups, hydrophilic catheter usage was associated with reduced numbers of treated UTIs as compared with standard nonhydrophilic catheters in persons with spinal cord injury who used self-IC; however, the study is limited by a small sample size. Women on self-IC were more likely to develop UTIs regardless of the catheter type, suggesting that the benefits of the lubrication may be more important in men.

J Spinal Cord Med. 2009;32(1):6-24.
Measuring depression in persons with spinal cord injury: a systematic review.
Kalpakjian CZ, Bombardier CH, Schomer K, Brown PA, Johnson KL.
Background/objective: Depression has been studied extensively among people with spinal cord injury (SCI). However, basic questions persist regarding the reliability and validity of depression measurement in the context of SCI. The objective of this study was to evaluate the state of knowledge of depression measurement in persons with SCI. Methods: English-language peer-reviewed citations from MEDLINE, CINAHL, PsycINFO, ProQuest, Google Scholar, and Web of Science from 1980 to present. Two reviewers screened 377 abstracts on SCI and depression topics to identify 144 containing classifiable psychometric data. All 144 were reviewed by 6 reviewers. Twenty-four studies reporting psychometric data on 7 depression measures in SCI samples were identified, including 7 validity studies. Results: Reliability data were limited to internal consistency and were
consistently good to excellent across 19 studies. Validity data were limited to concurrent validity, construct validity, and/or clinical utility in 10 studies. Measures were comparable with respect to internal consistency, factor structure, and clinical utility. Results are limited to peer-reviewed, English literature, and studies were not judged for quality. Conclusions: Greater attention should be paid to the psychometric evaluation of established measures. Although existing evidence may not justify universal screening, we recommend depression screening in clinical practice when patients may be seen by nonpsychology personnel. There is insufficient evidence to recommend one screening measure over another. Therefore, selection of measures will depend on clinician preferences. Psychometric studies are needed to show test-retest reliability, criterion validity, and sensitivity to change to improve depression recognition and treatment.

J Spinal Cord Med. 2009;32(5):568-73.
Validity, Accuracy, and Predictive Value of Urinary Tract Infection Signs and Symptoms in Individuals with Spinal Cord  Injury on Intermittent Catheterization

Massa L, Hoffman JM, Cardenas DD.
BACKGROUND/OBJECTIVE: To determine the validity, accuracy, and predictive value of the signs and symptoms of urinary tract infection (UTI) for individuals with spinal cord injury (SCI) using intermittent catheterization (IC) and the accuracy of individuals with SCI on IC at predicting their own UTI. DESIGN: Prospective cohort based on data from the first 3 months of a 1-year randomized controlled trial to evaluate UTI prevention effectiveness of hydrophilic and standard catheters. PARTICIPANTS: Fifty-six community-based individuals on IC. MAIN OUTCOME MEASURES: Presence of UTI as defined as bacteriuria with a colony count of at least 10(5) colony-forming units/mL and at least 1 sign or symptom of UTI. METHODS: Analysis of monthly urine culture and urinalysis data combined with analysis of monthly data collected using a questionnaire that asked subjects to self-report on UTI signs and symptoms and whether or not they felt they had a UTI. RESULTS: Overall, "cloudy urine" had the highest accuracy (83.1%), and "leukocytes in the urine" had the highest sensitivity (82.8%). The highest specificity was for "fever" (99.0%); however, it had a very low sensitivity (6.9%). Subjects were able to predict their own UTI with an accuracy of 66.2%, and the negative predictive value (82.8%) was substantially higher than the positive predictive value (32.6%). CONCLUSIONS: The UTI signs and symptoms can predict a UTI more accurately than individual subjects can by using subjective impressions of their own signs and symptoms. Subjects were better at predicting when they did not have a UTI than when they did have a UTI.

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2008

J Spinal Cord Med. 2008;31(2):177-84.
Improving the efficiency of screening for major depression in people with spinal cord injury.
Graves DE, Bombardier CH.
BACKGROUND/OBJECTIVE: To investigate the metric properties, relative efficiency, sensitivity and specificity, and positive predictive value of a short form of the Patient Health Questionnaire-9 (PHQ-9) that may be used as a screening test for depression. METHODS: Data from the National Spinal Cord Injury Statistical Center
Database containing 3,652 records with complete data for the PHQ-9 were analyzed using Confirmatory Factor Analysis, Item Response Theory Graded Response Model analysis, and sensitivity and specificity analysis of classification. RESULTS: A scale comprised of items 1, 2, and 6 from the PHQ-9 has a relative efficiency of
0.66 compared to the 9-item scale. Using this 3-item scale and a cutoff score of 3 or more provides specificity of 0.93 and sensitivity of 0.87; a cutoff of 4 provides specificity of 0.95 and sensitivity of 0.82. The shorter version of the scale reduces the effect of response bias caused by gender. The relative efficiency of the 9-item scale is 0.88 for women compared to men; the 3-item scale increases the relative efficiency to 0.93. CONCLUSION: A 3-item scale provides adequate information for clinical screening purposes. Cutoff scores of either 3 or 4 are acceptable and present options for decision making within a particular clinical setting. Additionally, the 3-item scale reduces the effect of gender of the respondent on the score obtained.

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